Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003809
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Randomized Double Blind Placebo Controlled Phase III Evaluation of Cisplatin Placebo Versus Cisplatin C225 a MouseHuman Monoclonal Antibody to the Epidermal Growth Factor Receptor in Patients With Metastatic andor Recurrent Squamous Cell Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer
Detailed Description:
OBJECTIVES I Compare the efficacy survival and response rates and toxicity of cisplatin with or without monoclonal antibody C225 in patients with metastatic andor recurrent squamous cell head and neck cancer II Compare the correlation between epidermal growth factor receptor density and response and progression-free survival in these patients III Determine the steady state serum levels of monoclonal antibody C225 and the frequency of human antibody response to this monoclonal antibody in patients treated with the combination therapy
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to disease status newly diagnosed vs recurrent and ECOG status 0 vs 1 Patients are randomized to 1 of 2 treatment arms Arm I Patients receive monoclonal antibody C225 IV over 2 hours followed 1 hour later by cisplatin IV over 2 hours on day 1 of course 1 Monoclonal antibody C225 is administered over 1 hour on subsequent courses Arm II Patients receive placebo IV over 2 hours followed 1 hour later by cisplatin as in arm I on day 1 of course 1 Placebo is administered over 1 hour on subsequent courses Treatment continues every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Arm II patients who develop disease progression may then crossover to arm I treatment Patients are followed at 1 and 3 months and then every 3 months until disease progression
PROJECTED ACCRUAL A total of 114 patients will be accrued for this study within 14 months
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to disease status newly diagnosed vs recurrent and ECOG status 0 vs 1 Patients are randomized to 1 of 2 treatment arms Arm I Patients receive monoclonal antibody C225 IV over 2 hours followed 1 hour later by cisplatin IV over 2 hours on day 1 of course 1 Monoclonal antibody C225 is administered over 1 hour on subsequent courses Arm II Patients receive placebo IV over 2 hours followed 1 hour later by cisplatin as in arm I on day 1 of course 1 Placebo is administered over 1 hour on subsequent courses Treatment continues every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Arm II patients who develop disease progression may then crossover to arm I treatment Patients are followed at 1 and 3 months and then every 3 months until disease progression
PROJECTED ACCRUAL A total of 114 patients will be accrued for this study within 14 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E5397 | None | None | None |